Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-16

Study Completion Date

2009-04-15

Brief Summary

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The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary vaccination schedule of combined hepatitis A/hepatitis B vaccine.

This protocol posting deals with objectives \& outcome measures of the extension phase at year 6 through to 10.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

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Detailed Description

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To evaluate the long-term antibody persistence, volunteers will be bled at Years 6, 7, 8, 9 and 10 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations.

If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.

Conditions

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Hepatitis B Hepatitis A

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Twinrix Group

Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix in the primary study (208127/076)

Group Type EXPERIMENTAL

TWINRIX™ ADULT

Intervention Type BIOLOGICAL

2 doses IM injection in primary study

Engerix-B Additional Dose (Adult)

Subjects aged 16 years and above who received an additional dose of EngerixTM-B (adult dose).

Group Type EXPERIMENTAL

Engerix TM

Intervention Type BIOLOGICAL

If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.

Engerix-B Additional Dose (Pediatric)

Subjects under the age of 16 years who received an additional dose of EngerixTM-B (pediatric dose).

Group Type EXPERIMENTAL

Engerix TM

Intervention Type BIOLOGICAL

If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.

Interventions

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TWINRIX™ ADULT

2 doses IM injection in primary study

Intervention Type BIOLOGICAL

Engerix TM

If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subjects participating in this study should have participated in the primary study with combined hepatitis A/ hepatitis B vaccine.
* Written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood sampling visit of each year.

Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes